Filling A Critical Translation Gap: Wake Forest Clinical and Translational Science Institute (CTSI) Collaborates in $2.7M National Study to Empower the Participant Voice

Pioneering initiative will collect and share nationally data on clinical trial participants' perceptions throughout the United States.

November 16, 2020

Empowering the Participant VoiceWINSTON SALEM, NOVEMBER 16, 2020: Wake Forest School of Medicine will serve as one of six sites nationally for the study Empowering the Participant Voice: Collaborative Infrastructure and Validated Tools for Collecting Participant Feedback to Improve the Clinical Research Enterprise (PAR-19-099, 1-U01- TR003206).  The study is supported by the National Center for Advancing Translational Sciences (NCATS) as part of the national Clinical and Translational Science Award (CTSA) collaborative. This study will:

  • Utilize the Research Participant Perception Survey (RPPS), a breakthrough validated instrument for rapid collection of participant feedback through REDCap.
  • Establish a collaborative analytics dashboard to evaluate participant feedback data from across the nation.
  • Broadly disseminate the RPPS tool, making it available to other CTSA institutions, a network of 50+ academic medical centers, as well as the broader community of REDCap users.

Joseph Andrews, PhD Wake Forest CTSI’s Dr. Joseph Andrews (pictured at right) says efforts are underway to improve clinical trials nationally through Empowering the Participant Voice, a $2.7M study funded by the CTSA Collaborative Innovation Award. WFSM joins fellow CTSAs Vanderbilt University, Johns Hopkins University, Duke University, University of Rochester, and leading institution, Rockefeller University. The goal is to develop, implement, and nationally deploy a validated instrument called the Research Participant Perception Survey (RPPS) and a system of collaborative analytics dashboards collecting RPPS feedback.

Participants are an essential component of clinical trials—clinical trials don’t exist without them. Yet recruitment remains a challenge, and the data shows an alarming pattern: approximately 86 percent of clinical trials fail to meet their recruitment goals with average trial dropout rates rising to 19.1 percent in 2019. These data show a problem, but they also show clear feedback that participants aren’t satisfied with the clinical trial experience. What more could we learn if participants’ perspectives were collected proactively? As Dr. Andrews shares, “We want to better understand how we can improve the participant experience so that people are less reluctant to join clinical trials, and we're more likely to retain people who do join, rather than dropping out because of something that was preventable?”

The Backstory of the RPPS

Rhonda Kost, MD

Rockefeller’s Rhonda Kost, MD (pictured at left) serves as the study’s principal investigator. As Dr. Kost explains, hospitals have long featured a patient-centered focus with financially incentivized collection and monitoring of patient feedback. This same structure doesn’t exist for clinical trials, leading to what Kost writes is a “critical translational gap” in research. Kost wants to change that: “We need to know in a participant-centered way—just like there’s a whole patient-centered movement in hospitals—what [participants’] experiences are so that we can then optimize what happens upstream to improve their experiences.”

The Value of Participant Feedback

Stephanie S. Daniel, PhD

Stephanie Daniel, PhD, WFSM Professor and Vice Chair for Research, Family and Community Medicine, and Associate Director, CTSI Program in Community-Engaged Research (PCER), spoke about the value of participant feedback, saying “One thing that we commonly hear from our PCER Community Stakeholder Advisory Committee is that there's a lack of trust between the community and the Medical Center as a whole, particularly as it relates to research.”

Dr. Daniel and her team are excited about the RPPS and the opportunity it will provide for both the community and academic researchers, stating it is “a new and novel approach to being able to solicit feedback from our participants, regarding how we're doing as we interact and engage with them in the field.”

From a recruitment perspective, Dr. Daniel points out that “the [RPPS] survey allows us to potentially use the data as a recruitment tool that may help to alleviate some of the community concerns related to research participation.”

Kost led the creation of the RPPS through a series of multisite studies over 10 years. Her model for the tool? The same Centers for Medicare and Medicaid Service survey hospitals are required to perform. As barriers of survey length and implementation persisted, Kost and her team refined the RPPS through regression analysis and retesting, producing today’s powerful, validated shorter version. Kost says “we wrote this grant to solve those barriers. To build an infrastructure that streamlined the use of the [RPPS] tool to make it easier for investigators and institutions to use it. Because the goal is to get participant feedback, so that you can fix research, so that it serves both investigators and participants.”

Game-Changing: Empowerment and Equity

Andrews, who serves as the study’s principal investigator for Wake Forest, says the RPPS will not only give insight into the participant experience generally, but also provide data on the perspectives of underrepresented populations: “ultimately, it's equitable enrollment. It's serving the community, making sure that everybody has the opportunity to participate and that we're creating an environment where participation is a comfortable, convenient, and pleasant experience.” Kost agrees, saying, “the research hasn't really fulfilled its goal if it didn't incorporate the people that it ultimately needs to serve.”

Kost and Andrews see this study opening up a game-changing amount of insight into participant perspectives across the nation and beyond, allowing participants to speak into the research enterprise. Utilizing RPPS as a shared tool allows for unprecedented collaboration. As Kost put it, the RPPS provides “a way to have a valid measure to assess the impact of programs and innovations.” Measuring the impact of improvement, and sharing that insight, empowers both participant and investigator alike.

Questions on how this study will impact your Wake Forest clinical trials?

Reach out to Dr. Joe Andrews today at jandrews@wakehealth.edu.

 

The RPPS/REDCap project is also supported in part by an award to Rockefeller University from the National Center for Accelerating Translational Science, 1U TR0001866.